Proposals for the Integration of Modern Diagnostic Methods into the Statutory Health Insurance

The current Corona pandemic shows how important it is to provide the population with modern diagnostic methods and tests. Beyond their importance in combating the pandemic, however, they play a major role in the health care system in general. Almost two-thirds of all clinical diagnoses are largely based on laboratory tests. In vitro diagnostics (IVDs) are indispensable components for personalised treatments, especially in the case of cancer. Although IVDs play a central role in successful treatment, their inclusion into the German statutory health insurance system (GKV) is still insufficiently regulated. A team of researchers from the legal department of the Max Planck Institute for Social Law and Social Policy has developed solutions to improve the current legal situation, which have now been published in the journal Medizinrecht in two open access articles (volume 39, issues 10 and 11).

The researchers conclude that the integration of these services into the statutory health insurance system requires above all an appropriate balance between openness to innovation, patient safety and economic efficiency. Based on a comparative analysis of the access procedure in France, England and Australia, they show how fast, controlled and at the same time affordable access to medical care can be guaranteed. To achieve this, a number of adjustments would have to be made in the statutory health insurance, including provisional reimbursement, time-bound re-evaluation, health economic evaluation, transparency and the participation of manufacturers. The central goal must be to eliminate the initial uncertainty about new procedures in as short a time as possible by studying their effectiveness within the German health system. Based on the results, either the inclusion or the final exclusion of modern diagnostic procedures into the benefit basket of the German statutory health system could then be decided.

Original publications:

Hardenberg, Simone von; Domenici, Irene; Grinblat, Roman:
Einbindung neuer In-vitro-Diagnostika in die GKV – Lösungsansätze aus vergleichender Perspektive (Teil 1), in: Medizinrecht, 39 (2021) 10, pp. 875–880.

Hardenberg, Simone von; Domenici, Irene; Grinblat, Roman:
Einbindung neuer In-vitro-Diagnostika in die GKV – Lösungsansätze aus vergleichender Perspektive (Teil 2), in: Medizinrecht, 39 (2021) 11, pp. 964–970.